Approvals (Drugs@FDA)

METHYLENE BLUE

ZYDUS LIFESCIENCES · METHYLENE BLUE

ANDA215636Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215636
Sponsor name
ZYDUS LIFESCIENCES
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20231205
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      77370
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215636Orig1s000ltr.pdf
      Date
      20240131
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20250304
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20260331
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  4. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20260202
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    METHYLENE BLUE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      METHYLENE BLUE
      Strength
      5MG/ML (5MG/ML)
  2. Product number
    001
    Reference drug
    No
    Brand name
    METHYLENE BLUE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      METHYLENE BLUE
      Strength
      10MG/2ML (5MG/ML)
  3. Product number
    004
    Reference drug
    No
    Brand name
    METHYLENE BLUE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      METHYLENE BLUE
      Strength
      100MG/10ML (10MG/ML)
  4. Product number
    002
    Reference drug
    No
    Brand name
    METHYLENE BLUE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      METHYLENE BLUE
      Strength
      50MG/10ML (5MG/ML)
Harmonized identifiers (openFDA)
Application number
ANDA215636
Brand name
METHYLENE BLUE
Generic name
METHYLENE BLUE
Manufacturer name
Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc.
Product NDC
70771-1767, 70771-1768, 70771-1963, 70710-1837, 70710-1838, 70710-2083
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
METHYLENE BLUE
RxCUI
1737852, 1788984, 2199323
SPL ID
31d0470b-20e5-4d5e-b273-81d5dd6b2180, 9a71c3d4-778d-4566-a060-8ec69cf93871
SPL set ID
df3568d6-d509-4c93-9a92-0e3d1d8514dc, 8c56fbad-a449-4ed4-a55f-1694e4e8e26a
Package NDC
70771-1767-1, 70771-1767-5, 70771-1768-1, 70771-1768-5, 70771-1963-5, 70771-1963-1, 70710-1837-1, 70710-1837-5, 70710-1838-1, 70710-1838-5, 70710-2083-1, 70710-2083-5
UNII
T42P99266K
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.